Clincosm LogoSign in Get a demo

SMINC-3: Stockholm Myocardial Infarction With Nonobstructive Coronaries Study 3

Sponsor
Karolinska Institutet (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05426408
Collaborator
Region Stockholm (Other)
85
Enrollment
1
Arm
18.5
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The present pilot study will investigate the prevalence of CMD in an unselected cohort of patients with the working diagnosis MINOCA and to study if the diagnostic yield can be improved by adding adenosine to the CMR investigation. Patient will be their own controls.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Cardiac magnetic resonance imaging to study coronary microvascular dysfunction
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
85 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Patients will be their own controlsPatients will be their own controls
Masking:
None (Open Label)
Masking Description:
The investigators who will perform the evaluation of the CMR investigations will be blinded to all clinical data.
Primary Purpose:
Diagnostic
Official Title:
Stockholm Myocardial Infarction With Nonobstructive Coronaries Study 3 - Pilot Study of Prevalence of Coronary Microvascular Dysfunction in Myocardial Infarction With Nonobstructive Coronary Arteries
Anticipated Study Start Date :
Sep 15, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Mar 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Other: Patients with MINOCA undergoing CMR

Patients will be their own controls

Diagnostic Test: Cardiac magnetic resonance imaging to study coronary microvascular dysfunction
Myocardial perfusion mapping will be investigated after administration of adenosine

Outcome Measures

Primary Outcome Measures

  1. Diagnostic yield [Through investigation completion, usually 2 hours]

    To increase the diagnostic yield of CMR imaging in MINOCA as a working diagnosis

Secondary Outcome Measures

  1. Prevalence of CMD in MINOCA [Through investigation completion, usually 2 hours]

    To determine the proportion of patients with the working diagnosis of MINOCA who have CMD.

  2. Prevalence of CMD in different final MINOCA diagnoses [Through investigation completion, usually 2 hours]

    To study the proportions of CMD in patients with a CMR imaging diagnosis of myocardial infarction, Takotsubo, respectively myocarditis and compare them with the results from a healthy control group

  3. Angina pectoris [3 Months]

    To investigate the occurrence of angina pectoris before inclusion and after 3 months and relate it to CMD

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 79 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • a suspected diagnosis of MINOCA or takotsubo syndrome with coronary angiography without diameter stenosis ≥50%

  • age 35-80 years

  • reading and writing proficiency in Swedish

Exclusion Criteria:

  • Claustrofobia

  • Arrythmia and/or pacemaker (atrial fibrillation and AV-block I- III)

  • Asthma or severe chronic obstructive lung disease

  • eGFR < 30 ml/min

  • spontaneous coronary artery dissection

  • acute pulmonary embolism

  • acute myocardial infarction type 2

  • cardiomyopathy other than takotsubo syndrome

  • a previous myocardial infarction due to CAD

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Karolinska Institutet
  • Region Stockholm

Investigators

  • Principal Investigator: Per Tornvall, MD, Karolinska Instítutet

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Per Tornvall, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT05426408
Other Study ID Numbers:
  • SMINC-3
First Posted:
Jun 22, 2022
Last Update Posted:
Jun 22, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Myocardial Infarction
Infarction

Study Results

No Results Posted as of Jun 22, 2022